BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 24811568 · Received April 7, 2026

    Report

    Report Number
    1644408-2026-00560
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    OQG
    UDI-DI
    00888912100472
    PMA / PMN Number
    K130365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION: THE AGENT REPORTED "(A PATIENT WITH FMP CUP WAS DISLOCATING SO DOCTOR CONSTRAINED THEM)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 9 YEARS AND 1 WEEK APART. ITEM NUMBER: 932-44-760 ITEM DESCRIPTION: LINER 10 DEG HOODED-NEU, MP10, HXE-PLUS, 44MM LOT NUMBER: 816N1925 PART REVISION: F PRODUCT TYPE: HIP MANUFACTURE DATE: 11/16/16 EXPIRATION DATE: 11/12/21. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEMS ASSOCIATED WITH THIS INVESTIGATION WERE NOT RETURNED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE SURGERY WAS COMPLETED AS INTENDED AND WITHOUT INCIDENT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO DISLOCATION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, PATIENT BONE DETERIORATION, INADEQUATE SOFT TISSUE SUPPORT, PATIENT ACTIVITIES OR TRAUMA. CONTAINMENT: INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. DEVICE HISTORY RECORDS REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS A NONCONFORMANCE ASSOCIATED WITH THE CONCOMITANT PART # 400-04-440, HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 44MM WHICH DOCUMENTS THAT OUT OF 10 PARTS LOT 2 ITEMS WAS REJECTED AND SCRAPPED DURING FLOW BENCH VERIFICATION. ALL OTHER ITEMS IN THE LOT WERE MET WITH FIT, FORM AND FUNCTION REQUIREMENTS. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. COMPLAINT HISTORY: CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW.

    Description of Event or Problem · 0

    A PATIENT WITH FMP CUP WAS DISLOCATING SO DOCTOR CONSTRAINED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366857 DJO SURGICAL LINER 10 DEG HOODED-NEU, MP10, HXE-PLUS, 44MM OQG ENCORE MEDICAL LP 932-44-760 816N1925 00888912100472

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention 400-04-440 885B1016